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Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK)

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ClinicalTrials.gov Identifier: NCT04283331
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Beeran Meghpara, MD, Wills Eye

Brief Summary:
Compared to laser-assisted in situ keratomileusis (LASIK), Photorefractive Keratectomy (PRK) is associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. We hypothesize that the use of bandage contact lenses soaked in proparacaine will decrease pain levels compared to solely the use of bandage contact lenses after PRK.

Condition or disease Intervention/treatment Phase
Myopia Hypermetropia Refractive Errors Astigmatism Drug: Proparacaine Ophthalmic Phase 4

Detailed Description:

Photorefractive keratectomy (PRK) is a popular method for the correction of refractive errors. Compared to laser-assisted in situ keratomileusis (LASIK), PRK is often associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. It can also avoid other complications associated with LASIK including striae, folds, diffuse lamellar keratitis, and epithelial ingrowth. As a result, improved management of post-operative pain in patients undergoing PRK is critical in order encourage utilization and patient preference of this procedure.

The current standard of care for pain management after PRK is the use of a bandage soft contact lens (BSCL). BSCLs may speed reepithelialization and function as an adjunct for pain control.

Using a BSCL soaked in proparacaine has not yet been studied as a pain management method after PRK. Our hypothesis is that combining these two methods will result in greater pain reduction than using a BSCL alone, which is the current standard of care. Furthermore, soaking the BSCL in anesthetics will reduce the chance that patients can abuse anesthetic medication postoperatively, which is the concern when patients are sent home with anesthetic drops as is noted in several prior studies.

This study aims to explore the potential of an anesthetic soaked bandage soft contact lens in reducing pain levels compared to a bandage soft contact lens alone after PRK.

Study Goals:

  • To assess the perception of pain following photorefractive keratectomy with the utilization of an anesthetic soaked bandage soft contact lens versus control (BSCL only) using the Visual Analog Pain Scale.
  • To assess the effect of an anesthetic soaked bandage soft contact lens on re-epithelialization following photorefractive keratectomy versus control. This will be assessed on post-operative day 5 as whether there is a persistent epithelial defect or not, a binary outcome.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The laser vision technician will be the only member aware of which eye received the control vs intervention treatment.
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bandage Contact Lens + Proparacaine
The eye that receives a bandage contact lens soaked in proparacaine.
Drug: Proparacaine Ophthalmic
Each subject will have one eye randomized to receive a bandage contact lens soaked in anesthetic solution (proparacaine hydrochloride 0.5%) and the following eye will serve as a control and receive a bandage soft contact lens soaked in balanced salt solution, which is the current standard of care for PRK.
Other Names:
  • Proparacaine
  • proparacaine hydrochloride 0.5%

No Intervention: Bandage Contact Lens WITHOUT Proparacaine
The eye that receives a bandage contact lens (standard of care).



Primary Outcome Measures :
  1. Daily pain score at post-operative day 0 through post-operative day 5 [ Time Frame: 5 days ]

    Primary Outcome Measure is pain score at post-operative day 0 THROUGH post-operative day 5. Patients will be asked to fill out their score daily.

    The Wong-Baker Faces pain scale will be used to measure pain. This is a self-report measure of pain consisting of a series of faces with expressions of increasing distress. Each face is also given a numerical rating from 0 to 5, zero representing no pain and 5 representing worst pain.



Secondary Outcome Measures :
  1. Complete re-epithelialization at post-operative day 5 [ Time Frame: 5 days ]
    A binary outcome (yes/no) of whether the corneal epithelium has completely healed by post-operative day 5.

  2. Final refractive outcome at postoperative month 3 [ Time Frame: 3 Months ]
    Snellen visual acuity, both without correction and best corrected with a manifest refraction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All eyes approved for photorefractive keratectomy with Dr. Beeran Meghpara or Dr. Christopher Rapuano, with or without the assistance of residents.

Exclusion Criteria:

  • Patients undergoing unilateral procedure.
  • Eyes that experience complication during the photorefractive keratectomy procedure
  • Patients who are pregnant or breast feeding
  • Patients under 18 years of age
  • Patients with a history of eye surgery or trauma and those with irregular astigmatism, keratoconus, or any other type of corneal disorder, pregnancy, diabetic retinopathy, or glaucoma.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283331


Contacts
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Contact: Beeran Meghpara, MD 2159283180 bmeghpara@willseye.org
Contact: Cherie A Fathy, MD, MPH 2159283000 cherie.fathy@jefferson.edu

Sponsors and Collaborators
Beeran Meghpara, MD
Investigators
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Principal Investigator: Beeran Meghpara, MD Wills Eye Hospital at TJUH
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Responsible Party: Beeran Meghpara, MD, Clinical Assistant Professor of Ophthalmology, Wills Eye
ClinicalTrials.gov Identifier: NCT04283331    
Other Study ID Numbers: 19-871
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Beeran Meghpara, MD, Wills Eye:
refractive surgery; PRK; LASIK
Additional relevant MeSH terms:
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Astigmatism
Refractive Errors
Hyperopia
Eye Diseases
Proxymetacaine
Propoxycaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents